איש קשר: משאבי אנוש
· Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on creating packaging and labeling artwork for labeling medical products and for submission to Health Authorities.
· Ensure that labeling, art including promotional materials meet all medical, legal and regulatory requirements in compliance with regulations, guidelines and procedures.
· Develops editor's copies and review artwork ensuring that all components meet the appropriate labeling requirements and guidelines. Gathers and evaluates all relevant information to support labeling changes for each project and maintains detailed audit trail.
· Under general supervision, participates in global labeling projects to completion, working closely with Regulatory, Quality, R&D and Clinical personnel for the design and to ensure accuracy of all labeling as well as timeliness of projects so that all commitments and deadlines are met.
· Facilitates the review and approval processes for new and post market change artwork and labeling from development through final proofs, including translations.
· Maintain working knowledge of computer software packages including CAD, MS Word, MS Excel, MS PowerPoint, Adobe, SharePoint and others as required.
· Bachelor's degree in an appropriate discipline, preferably with strong science background. Strong command of the English language required to be able to produce print-ready material.
· Must have 2 years minimum experience in the pharmaceutical/medical device industry, with specific
product labeling experience and/or demonstrated ability to process labeling within the skills defined
Preferred Knowledge, Skills and Abilities:
Graphics/ printing related experience in the pharmaceutical/medical device industry:
· Working knowledge of graphic design software applications such as CAD, with more advanced knowledge of Adobe Illustrator and Adobe Acrobat.
· Knowledge of ISO 15223: 2016
· Solution-driven attitude, ability to autonomously develop a course of action leading to a beneficial
· Ability to effectively operate in a multicultural environment which requires negotiation,
collaboration and adaptation.
· Ability to work with minimum/general supervision and escalate relevant information to
· Well-developed interpersonal and leadership skills.
· Strong organizational skills with demonstrated ability to effectively manage several projects in parallel.
סוג משרה:משרה מלאה